BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVER ARM MOTOR UNIT

    MDR report key: 17857713 · Received October 2, 2023

    Report

    Report Number
    2027754-2023-00034
    Event Type
    Malfunction
    Date Received
    October 2, 2023
    Report Date
    October 2, 2023
    Manufacturer
    OSTEOMED, LLC
    Product Code
    KMW
    UDI-DI
    00845694015646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAD BEEN RETURNED UNDER A SERVICE WORK ORDER (SRO) DURING WHICH IT WAS IDENTIFIED THAT THE DEVICE WAS CONTINUOUSLY RUNNING DUE TO MALFUNCTION OF THE CABLE ASSEMBLY. THE DEVICE IS A REUSABLE INSTRUMENT AND WAS MANUFACTURED IN 2020; THEREFORE, IT IS UNKNOWN HOW MANY TIMES THE DEVICE WAS USED PRIOR TO THIS REPORTED COMPLAINT EVENT NOR UNDER WHAT CIRCUMSTANCES IT WAS USED. THE DEVICE WAS TESTED PER OTR 0060 REV E UPON MANUFACTURE AND MET ALL SPECIFICATIONS. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    SERVICE REQUEST FOR THE DEVICE WAS RECEIVED WITH NO PRODUCT COMPLAINT MADE. ON (B)(6) 2023. THE SERVICE REQUEST WORK ORDER DEVICE DIAGNOSIS WAS COMPLETED. DURING THE SERVICE REQUEST WORK ORDER, IT WAS NOTED THE DEVICE WAS RUNNING CONTINUOUSLY DUE TO A MALFUNCTIONING CABLE ASSEMBLY, AND MOTOR UNIT ALSO HAS WORN AND DIRTY ROTOR ASSEMBLY". AS A RESULT OF THESE FINDINGS OF THE SERVICE REQUEST WORK ORDER, THIS REPORT IS BEING SUBMITTED. ADDITIONALLY, AS A RESULT OF THE SERVICE REQUEST WORK ORDER, THE CUSTOMER WAS CONTACTED TO DETERMINE IF ANY SURGERY OR PATIENT WAS IMPACTED. THE CUSTOMER RESPONDED THAT THIS ISSUE WAS NOTED IN THEIR WAREHOUSE POST SURGERY WITH NO PATIENT, USER, OR SURGERY INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553295 LEVER ARM MOTOR UNIT HANDPIECE, ROTARY BONE CUTTING KMW OSTEOMED, LLC 450-0034 1145682 00845694015646

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown